Antares Pharma announced the availability of Xyosted injection. Xyosted is the only FDA approved subcutaneous testosterone product for once-weekly, at-home self-administration with a single dose, disposable QuickShot auto injector. Xyosted has been approved in three dosage strengths and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Xyosted was approved by the FDA on September 28.

Antares Pharma (ATRS) announced that Teva Pharmaceutical Industries (TEVA) generic EpiPen is now commercially available in limited quantities. Teva's generic EpiPen was approved by the FDA on August 16 and is indicated for emergency treatment of severe allergic reactions including those that are life threatening in adults and certain pediatric patients. The product, which utilizes the Antares Pharma VIBEX auto injector, has been approved as therapeutically equivalent and fully substitutable to the EpiPen at the pharmacy. Antares previously entered into an exclusive License, Development and Supply Agreement with Teva for an epinephrine auto injector product to be marketed in the U.S. Pursuant to the agreement, Antares is responsible for supply of the device which will be sold to Teva at cost plus margin. Teva is responsible for commercialization and distribution of the final product for which Antares will receive royalties on net sales.

30th Annual Healthcare Conference will be held in New York on November 27-29 with webcasted company presentations to begin on November 27 at 8 am; not all company presentations may be webcasted. Webcast Link

30th Annual Healthcare Conference will be held in New York on November 27-29 with webcasted company presentations to begin on November 27 at 8 am; not all company presentations may be webcasted. Webcast Link

Antares Pharma announced that data from the 26-week Phase 3 study of the safety and tolerability of XYOSTED will be presented as a moderated poster presentation on Friday November 9 at the 24th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America. The poster entitled "Effect of Testosterone Enanthate on 24-hour Ambulatory Blood Pressure is Less in Patients with Hypertension at Baseline" will be presented by Mohit Khera, MD, Laboratory for Andrology Research, Baylor College of Medicine, Houston Tx. The submission was among a select group of key abstracts awarded the distinction of a moderated poster presentation. The Phase 3, 26-week, dose-blind, multicenter trial of XYOSTED, a proprietary, pre-filled subcutaneous testosterone enanthate auto-injector administered weekly, examined 133 hypogonadal adult men with baseline testosterone evels of less than300 ng/dL. Patients received 75 mg of testosterone enanthate administered via auto injector once-weekly for 6 weeks. At week 7, dose adjustments were conducted according to a simple titration scheme if necessary and were based on week-6, pre-dose blood levels in the patients. The XYOSTED clinical program included a rigorous ambulatory blood pressure monitoring study to fully characterize the potential side effects of testosterone replacement on blood pressure.

Antares Pharma price target raised to $8 from $7 at Jefferies. Jefferies analyst Anthony Petrone raised his price target on Antares Pharma shares to $8 from $7 following the company's Q3 report and operating update. Petrone keeps a Buy rating on Antares shares, which are up 3c, or 1%, to $3.53 in afternoon trading.

Reports Q3 revenue $17.87M, consensus $15.05M. "The third quarter of 2018 was exceptional for the Company with record revenue reported and a significant number of operational achievements highlighted by the approvals of XYOSTED and Teva's generic EpiPen. Antares also entered into an agreement with Pfizer to develop a rescue pen utilizing our QuickShot device with an undisclosed drug. This is an exciting opportunity and enhances our expanding pipeline of proprietary and partnered products. We believe each one of these important milestones will help drive positive momentum during the balance of this year and beyond. We look forward to the 2018 launch of XYOSTED, the only subcutaneous auto injector product approved for testosterone deficiency as well as Teva's launch of the first and only fully substitutable generic EpiPen. We believe these new sources of revenue, combined with the revenue stream from the Makena auto injector, which was also FDA approved and launched in 2018, will ultimately increase shareholder value," said CEO Robert Apple earlier this morning as part of the company's Q3 earnings report press release.

Jefferies raises Antares Pharma price target to $7, sees possible upside to $15. Jefferies analyst Anthony Petrone raised his price target on Antares Pharma to $7 from $5, calling FDA approval of Xyosted a "game changer." He does not believe the inclusion of a black box warning in the label is a significant surprise nor a deal breaker for doctors, Petrone tells investors. The analyst, who thinks the company could take anywhere from 20% to 60% of the $1.5B-$2.0B TRT market over time, sees upside to $15 on a strong roll out of Xyosted, he added. Petrone keeps a Buy rating on Antares shares, which are up 17.5% to $3.83 in afternoon trading.